CN102628832A - Analyzing device, sensor testing device and testing method - Google Patents

Abstract

There is provided a sensor testing method including: applying at least one of a first voltage that obtains a response caused by a substance and a second voltage that either obtains no response or substantially no response caused by the substance across a first electrode and a second electrode of a sensor; measuring current flowing between the first electrode and the second electrode; and determining whether or not there is a defect present in the sensor based on a quantity related to an amount of change per specific period of time of a current measured when the first voltage and/or the second voltage have been applied.

Description

Analytical equipment, sensor testing fixture and inspection method

Technical field

The present invention relates to analytical equipment, sensor testing fixture and inspection method and computer-readable recording medium.

Background technology

Exist to being provided with many group working electrodes and coming the relevant proposal (referring to the instructions of for example United States Patent(USP) No. 7190988 and United States Patent(USP) No. 6121009) of electrochemica biological sensor of the defective of detecting sensor to electrode and through the response between each electrode group relatively.

Also exist to being used for regulating from the proposal (referring to the for example instructions of United States Patent(USP) No. 6895263) of the method for the data collected of electrochemica biological sensor.In the technology of the instructions of United States Patent(USP) No. 6895263, come the calculation correction characteristic based on the current sensor data point, and confirm possible mistake or change of sensitivity according to this correcting feature.In order to confirm whether correcting feature at this moment is uncertain, between estimated value relevant with this correcting feature and correcting feature at this moment, compares, to confirm fault or the variation of transducer sensitivity aspect in this sensor.The estimated value relevant with this correcting feature confirm according at that time correcting feature and according to passing correcting feature, and when receiving unsupported each other at least two uncertain correcting features continuously, confirm out of order sensor.

Also there is proposal to the electrochemical sensor monitoring device that the electrochemical sensor that is formed by two electrode groups or three electrode groups is installed; In said electrochemical sensor; The electric current that detection is flowed between at working electrode and to electrode; Transient response time to till reaching steady state (SS) up to electric current is counted, and confirms sensor mass (opening (JP-A) No.2004-233294 referring to for example japanese patent application laid) with reference to the relation between this transient response time and the corrected value.

Yet, because the many groups working electrode that in the technology of United States Patent(USP) No. 7190988 and 6121009, provides and to electrode between carry out relatively, so should technology can not confirm aspect absolute term whether each electrode group normal.Specifically; Because the electrode group in the electrochemica biological sensor is miniature aspect size; So conceivable is that all the electrode groups in the sensor are damaged simultaneously, and appearance can not be through carrying out the problem of relatively coming stably to check sensor states.And, because need multi-group electrode, thus from make and the viewpoint of cost this also be harmful to.

In the technology of United States Patent(USP) No. 6895263, because confirm out of order sensor, so aspect confirming, exist uncertain based on the estimated value that adopts sampled data to calculate.

In the technology of JP-ANo.2004-233294, existing problem is that the time till reaching steady state (SS) maybe be elongated.

Summary of the invention

In view of the foregoing, the present invention is devoted to a kind ofly can stably check sensor status in the very short time and analytical equipment and the sensor testing fixture and the inspection method thereof of a plurality of electrode groups need be set.

Analytical equipment according to a first aspect of the invention comprises: sensor part; This sensor part comprises reagent layer, electrode and outer membrane; Said reagent layer comprise with sample liquid in the reagent of substance reaction; Said electrode comprises first electrode and second electrode that is used for applying to said reagent layer voltage, and said outer membrane is used for contacting with said reagent layer; Voltage applying unit; This voltage applying unit is used between said first electrode and said second electrode, applying at least one of first voltage and second voltage; Said first voltage obtains the response that is caused by said material, and said second voltage does not obtain or do not obtain basically the response that is caused by said material; Current measuring unit, this current measuring unit are used to measure the electric current that between said first electrode and said second electrode, flows; And definite unit; Should confirm that unit was used for confirming whether there is defective in the said outer membrane based on first physical quantity and second physical quantity at least one; Said first physical quantity is relevant with the variable quantity of every special time of first electric current of when having applied said first voltage, having been measured by said current measuring unit, and said second physical quantity is relevant with the variable quantity of every special time of second electric current of when having applied said second voltage, having been measured by said current measuring unit.

According to above analytical equipment; Sensor part comprises reagent layer, electrode and outer membrane; Said reagent layer comprise with sample liquid in the reagent of substance reaction; Said electrode comprises first electrode and second electrode that is used for applying to said reagent layer voltage, and said outer membrane is used for contacting with said reagent layer.(said first voltage obtains the response that is caused by said material when said voltage applying unit applies in first voltage and second voltage at least one between said first electrode and said second electrode; Said second voltage does not obtain or does not obtain basically the response that is caused by said material) time, said current measuring unit is measured the electric current that between said first electrode and said second electrode, flows.Then; Said definite unit confirms whether there is defective in the said outer membrane based in first physical quantity and second physical quantity at least one; Said first physical quantity is relevant with the variable quantity of every special time of first electric current of when having applied said first voltage, having been measured by said current measuring unit, and said second physical quantity is relevant with the variable quantity of every special time of second electric current of when having applied said second voltage, having been measured by said current measuring unit.Said first physical quantity and said second physical quantity can be the variable quantities of every special time of each electric current itself, or other physical quantity that can derive from the variable quantity of every special time of said each electric current itself.

Therefore; (said first voltage obtains the response that is caused by said material with in having applied said first voltage and said second voltage at least one through adopting; Said second voltage does not obtain or does not obtain basically the response that is caused by said material) time the relevant physical quantity of change in current amount check the state of said outer membrane; Can be stably and in the said sensor status of very short time check, and multi-group electrode need be set.

Said first physical quantity can be the very first time till the variable quantity up to said every special time of said first electric current reaches the value in predetermined first particular range, and said second physical quantity can be second time till the variable quantity up to said every special time of said second electric current reaches the value in predetermined second particular range.Through utilizing these physical quantitys, reach the situation of the time of steady state (SS) with the employing electric current and compare, can go out the defective that exists in the said outer membrane in very short time detecting.

Said analytical equipment can also comprise correcting unit; Proofread and correct the said current value of being measured by said current measuring unit when this correcting unit is confirmed defective to have occurred in the said outer membrane in said definite unit, at least one during said correcting unit concerns based on second of being scheduled between the ratio of defects of the first predetermined relation between the ratio of defects of said first physical quantity and said outer membrane and said second physical quantity and said outer membrane carried out correction.In other words, said first physical quantity and said second physical quantity when applying said first voltage and said second voltage respectively, obtained change in response to the said ratio of defects of said outer membrane.Therefore, can proofread and correct measured current value based on the said ratio of defects that derives from these physical quantitys.More particularly; During said correcting unit can concern based on said first relation and said second at least one estimated said ratio of defects; And the predetermined relationship between the said current value of measuring based on the said ratio of defects of said outer membrane and from following sensor part is proofreaied and correct the said current value of being measured by said current measuring unit, and wherein this sensor part is provided with and has and the corresponding external defect sealing film of said ratio of defects.

When said correcting unit based on said first relation with said second when concern that the two estimates said ratio of defects, said correcting unit can calculate based on said first concern first ratio of defects that estimates and based on said second concern second ratio of defects that estimates mean value, maximal value or minimum value as said ratio of defects.

Said analytical equipment can also comprise output unit, and output was illustrated in the signal that has occurred defective in the said sensor part when this output unit was confirmed defective to have occurred in the said outer membrane in said definite unit.

In said analytical equipment, apply said first voltage and said second voltage the two time, said voltage applying unit can alternately apply said first voltage and said second voltage.

In said analytical equipment, the electric current that said current measuring unit can continuous coverage flows between said first electrode and said second electrode, and said definite unit can regularly confirm whether there is defective in the said outer membrane by predetermined.Because hope can be very effective so use analytical equipment of the present invention at the said sensor of very short time check in the device of continuous monitoring electric current (for instance, like continuous blood sugar monitor) in such a way.

During using said analytical equipment, said sensor part can be set under user's the skin of said analytical equipment, and said reagent layer reacts with the composition to be checked that is present in said skin under.

And said reagent layer can extract electronics from said composition to be checked, and can the electronics that extracted be offered said electrode.

And said reagent layer can comprise the enzyme part that is used for extracting from said composition to be checked electronics.

Sensor testing fixture according to a second aspect of the invention comprises: voltage applying unit; This voltage applying unit applies at least one in first voltage and second voltage between first electrode of sensor part and second electrode; This first voltage obtains the response that is caused by material; This second voltage does not obtain or does not obtain basically the response that is caused by said material; Said sensor part disposes reagent layer, electrode and outer membrane; Said reagent layer comprise with sample liquid in the reagent of said substance reaction, said electrode comprises said first electrode and said second electrode that is used for applying to said reagent layer voltage, said outer membrane is used for contacting with said reagent layer; Current measuring unit, this current measuring unit is measured the electric current that between said first electrode and said second electrode, flows; And definite unit; Should confirm unit confirms whether there is defective in the said outer membrane based in first physical quantity and second physical quantity at least one; Said first physical quantity is relevant with the variable quantity of every special time of first electric current of when having applied said first voltage, having been measured by said current measuring unit, and said second physical quantity is relevant with the variable quantity of every special time of second electric current of when having applied said second voltage, having been measured by said current measuring unit.For example, can adopt this device to come the state of the said outer membrane of (as in the factory that makes sensor) inspection sensor in sensor manufacturing process.

Sensor inspection method according to a third aspect of the invention we may further comprise the steps: between first electrode of sensor part and second electrode, apply at least one in first voltage and second voltage; This first voltage obtains the response that is caused by material; This second voltage does not obtain or does not obtain basically the response that is caused by said material; Said sensor part disposes reagent layer, electrode and outer membrane; Said reagent layer comprise with sample liquid in the reagent of said substance reaction, said electrode comprises said first electrode and said second electrode that is used for applying to said reagent layer voltage, said outer membrane is used for contacting with said reagent layer; The electric current that measurement is flowed between said first electrode and said second electrode; And confirm whether there is defective in the said outer membrane based in first physical quantity and second physical quantity at least one; Said first physical quantity is relevant with the variable quantity of every special time of first electric current of when having applied said first voltage, having measured, and said second physical quantity is relevant with the variable quantity of every special time of second electric current of when having applied said second voltage, having measured.

Therefore; (said first voltage obtains the response that is caused by said material with in having applied said first voltage and said second voltage at least one through adopting; Said second voltage does not obtain or does not obtain basically the response that is caused by said material) time the relevant physical quantity of change in current amount; Check the state of said outer membrane, can be stably and in the said sensor status of very short time check, and multi-group electrode need be set.

Description of drawings

Based on following accompanying drawing, illustrative embodiments of the present invention is described in detail, in the accompanying drawing:

Fig. 1 is the cross section of the continuous glucose monitoring device of illustrated example property embodiment;

Fig. 2 is the enlarged drawing of a part of stereographic map and this sensor part of sensor part;

Fig. 3 is the cross section of the end (electrode part) of illustration sensor part;

Fig. 4 is the block diagram of the schematic configuration of exemplary circuit plate;

Fig. 5 is the curve map of the response current of illustration when having applied response voltage;

Fig. 6 shows the image of state of the CA film of sensor part;

Fig. 7 is illustrated in the curve map that has applied the variation in the response voltage response current afterwards;

Fig. 8 is illustrated in when having applied response voltage variable quantity up to response current to become than the curve map of the time till little to the variable quantity threshold value of each sensor with different CA membrane stages;

Fig. 9 is illustrated in the process flow diagram that the checking mode of carrying out in the continuous glucose monitoring device of first illustrative embodiments is handled routine;

Figure 10 is that the variable quantity up to response current that is illustrated in when having applied response voltage becomes less than the curve map of time till the variable quantity threshold value and the relation between the ratio of defects;

Figure 11 A and Figure 11 B be illustration ratio of defects and sensitivity normal-curve map of relation between the mistake difference;

Figure 12 is illustrated in the curve map that is directed against each sensor's response change in current amount with different CA membrane stages when having applied response voltage;

Figure 13 is illustrated in the process flow diagram that the checking mode of carrying out in the continuous glucose monitoring device of second illustrative embodiments is handled routine;

Figure 14 is illustrated in the variable quantity of the response current when having applied response voltage and the curve map of the relation between the ratio of defects;

Figure 15 A is illustrated in the curve map that has applied the variation in the response voltage response current afterwards, and Figure 15 B is illustrated in the curve map that has applied the variation in the non-response voltage response current afterwards;

Figure 16 A and Figure 16 B are illustrated in the variable quantity up to response current when having applied response voltage to become than the curve map of the time till little to the variable quantity threshold value of each sensor with different CA membrane stages; Curve map when wherein Figure 16 A illustration has applied response voltage, and the curve map of Figure 16 B illustration when having applied non-response voltage;

Figure 17 is illustrated in the process flow diagram that the checking mode of carrying out in the continuous glucose monitoring device of the 3rd illustrative embodiments is handled routine;

Figure 18 A and Figure 18 B are that illustration becomes less than the curve map of time till the variable quantity threshold value and the relation between the ratio of defects up to the variable quantity of response current; Curve map when wherein Figure 18 A illustration has applied response voltage, and the curve map of Figure 16 B illustration when having applied non-response voltage;

Figure 19 is the curve map to each sensor's response change in current amount with different CA membrane stages that is illustrated in when having applied non-response voltage;

Figure 20 is illustrated in the variable quantity of the response current when having applied non-response voltage and the curve map of the relation between the ratio of defects;

Figure 21 shows the diagram of other example of example voltages pattern; And

Figure 22 A and Figure 22 B show the cross section of other example of the end (electrode part) of illustration sensor part.

Embodiment

Followingly come illustrative embodiments of the present invention is described with reference to accompanying drawing.In this illustrative embodiments, the situation that analytical equipment of the present invention is applied to continuous glucose monitoring (CGM) device is described.

(first illustrative embodiments)

As shown in Figure 1, the continuousglucose monitoring device 1 of this illustrative embodiments is configured to compriseshell 2,circuit board 3 and sensor part 4.This continuousglucose monitoring device 1 is applied to such as the belly of human body or theskin 6 of shoulder regions, and the concentration of the glucose in continuous monitoring blood or the subcutaneous interstitial fluid.

Shell 2 is configured thelid 20 andbase portion 21 of the profile that forms continuous glucose monitoring device 1.Lid 20 is bonded together withbase portion 21, so thatcircuit board 3 is contained in the space that is formed betweenlid 20 and the base portion 21.Material (for example, metal or acrylic resin) with extremely low moisture transmission is preferably used forshell 2.

Base portion 21 is formed with the patchhole that is used to insertsensor part 4, and theend 40 ofsensor part 4 is fixed on the inner face of base portion 21.Bonding film 5 is set on the outside of base portion 21.On two faces ofbonding film 5, adopt adhesivetape.Bonding film 5 itself is attached tobase portion 21 through the adhesive tape on the one side, andglucose monitoring device 1 is attached toskin 6 through the adhesive tape on the another side continuously.

Circuit board 3 is equipped with to the required electrical arrangement element of the overall control of this continuous glucose monitoring device 1.Circuit board 3 is configured to comprise after a while the connectingportion 30 that being used for of describing contacts with the electrode 42 (referring to Fig. 2) of sensor part 4.Adopt connectingportion 30 to come to apply voltage and obtain response current tosensor part 4.

Sensor part 4 is obtained the response based on the concentration of glucose in blood or the subcutaneous interstitial fluid.Thefirst end 40 ofsensor part 4 contacts with the connectingportion 30 ofcircuit board 3, and the second end ofsensor part 4 is inserted in theskin 6.

As shown in Figure 2,sensor part 4 is configured to comprisebase portion 41,electrode 42 andenzyme part 43.

Base portion 41 is pressed configuration of sheet shape andsupport electrode 42 by the electrically insulating material of flexibility.Theend 41B in a side that is used for being inserted intoskin 6 ofbase portion 41 is formed with sharp-pointed profile, makessensor part 4 can be easily inserted in theskin 6, thereby makes it possible to alleviate user's pain.Yet, there is not special restriction in the profile of the front end ofbase portion 41, but can utilizes other profile except the sharpening profile to construct.Can not be adopted as the material that is used forbase portion 41 so that do not influence the material of human body with having suitable electrical insulation characteristics; And; For example, can adopt for this reason such as polyethylene terephthalate (polyethylene terephthalate) (PET), polypropylene (polypropylene) (PP) or tygon (polyethylene) thermoplastic resin (PE).Can also adopt thermoset resin such as polyimide resin or epoxy resin for this reason.

Electrode 42 is configured to comprise the 42A of working electrode portion and to electrode part 42B.Through applying voltage toelectrode 42, electric current and the electronics (describing after a while) that is extracted byenzyme part 43 flow at the 42A of working electrode portion and between toelectrode part 42B accordingly.

Enzyme part 43 is used for extracting electronics from glucose, and makes the electronics that is extracted traverse into the 42A of working electrodeportion.Enzyme part 43 can for example be arranged on the glucose oxidoreductase on the 42A of working electrode portion.Glucose oxidase (GOD) or GDH (GDH) can be adopted to glucose oxidoreductase.Can adopt known method as the method that is used to adhere to this glucose oxidoreductase; For instance; As adopt following method: use polymerizable gel, polyacrylamide or such as the method for the polymkeric substance of phosphorus; Use utilizes the method for MPC polymkeric substance of the phospholipid polyalcohol of silane coupling agent coupling, perhaps utilizes the method for protein coat.

Fig. 3 schematically illustration the cross-sectional configuration ofend 41B of sensor part 4.The 42A of working electrode portion andelectrode part 42B is formed on thebase portion 41, and form semipermeable partition, to cover the workingelectrode 42A of portion.The zone that is made up ofbase portion 41 andsemipermeable partition 45 is areagent layer 44, andenzyme part 43 is set in the reagent layer 44.Enzyme part 43 needn't stick on the 42A of working electrode portion, and can construct so thatenzyme part 43 is set in thereagent layer 44 of the 42A of working electrode portion top, but does not contact with workingelectrode 42A.

Semipermeable partition 45 is configured to prevent that transducer sensitivity from becoming saturated immediately, for example, but prevents the saturated upper limit that reaches to the glucose detectable concentration of sensor of sensitivity, andsemipermeable partition 45 restriction glucose lead to enzyme part 43.Semipermeable partition 45 also suppresses to hinder the interfering material of reaction to reach enzyme part 43.Can adopt CAM or polyurethane film as semipermeable partition 45.In this illustrative embodiments, describe as the situation of semipermeable partition 45 (CA film hereinafter referred to as) adopting CAM.It should be noted thatsemipermeable partition 45 is examples of the outer membrane among the present invention.Yet outer membrane is not limited to have restriction glucose and leads to the material of the characteristic ofenzyme part 43.

The method that formssensor part 4 for example is: the serigraphy through adopting carbon ink is formed on thebase portion 41 with the 42A of working electrode portion with toelectrode part 42B; Covalency keyed jointing carbodiimides at this 42A of working electrode portion and on toelectrode part 42B; Utilize glutaraldehyde to drip the bridge joint glucose oxidoreductase at this 42A of working electrode portion with on, and then utilize the warm air drying to reach 15 minutes at 40 ℃ to electrodepart 42B as bridging agent (bridging agent).Then, can utilize spin coating or dip-coating to form the CA film, cover to form as semipermeable partition 45.Can also utilize such as the compound of two (sulfosuccinic acylimino) suberate (bis (sulphosuecinimidyl) suberate) or two-N-succinyl imino group-(nine polyglycol) ester (bis-N-succinimidyl-(nonaethylene glycol) ester) and construct.

As shown in Figure 4,circuit board 3 is configured to comprise connectingportion 30 and also comprises communication unit 31, power supply 32, control module 33, computing unit 34 and storage unit 35.

Communication unit 31 is being carried out data communication betweenglucose monitoring device 1 and the external data treatment facility continuously.Communication unit 31 is configured to comprise at least one transmitting element, and also comprises receiving element when needed.Data communication can be through for example carrying out such as the radio communication of infrared communication or bluetooth (Bluetooth).Can also construct so that carry out wired data communication; And in these cases; For example, the cable connecting portion is arranged to the communication unit 31 of continuousglucose monitoring device 1, so that carry out data communication through utilizing cable to be connected to the external data treatment facility.

The example of external data treatment facility comprises such as the equipment that is used for the insulin generator to the human body administration of insulin, simple blood glucose measurement instrument, Wrist watch type display device and personal computer (PC).

In the data communication between continuousglucose monitoring device 1 and simple blood glucose measurement instrument, for example, can the blood glucose measurement result of simple blood glucose measurement instrument be sent to continuous glucose monitoring device 1.Therefore can the measurement result of continuousglucose monitoring device 1 be compared with the blood glucose measurement result who receives from simple glucometer device, make it possible to carry out correction the measurement result of continuous glucose monitoring device 1.Can construct so that the data of being measured by continuous glucose monitoring device 1 (current value) are sent to simple blood glucose measurement instrument, calculate these blood glucose values itself so that fall into a trap at simple blood glucose measurement instrument.

In the data communication between continuousglucose monitoring device 1 and Wrist watch type display device, for example, can the measurement result of continuousglucose monitoring device 1 be sent to the Wrist watch type display device.Even when continuousglucose monitoring device 1 being mounted to the position (such as user's shoulder or abdomen area) that the user is difficult to see, this method also makes the user can confirm measurement result easily.

Data communication between continuousglucose monitoring device 1 and PC for example makes it possible to the data of being measured by continuous glucose monitoring device 1 (current value) are sent to PC.Can show concentration of glucose trend, and then can carry out various analyses by PC.Can construct so that correction data etc. is sent to continuousglucose monitoring device 1 from PC.

Power supply 32 is to be used for tocircuit board 3 andsensor part 4 direct current power source supplying power, and for example can to adopt supply voltage be the battery of 1V to 3V.

Control module 33 is the continuousglucose monitoring device 1 of control totally, the aspect that control for example applies timing, response current sampling, concentration of glucose computing and is directed against the communication of external data treatment facility such as voltage.

Computing unit 34 is carried out required various calculating in the processing in continuousglucose monitoring device 1, comprises the for example calculating of concentration of glucose.

To carry out that checking mode is handled the program of routine such as being used for of describing after a while, the program of the various programs that are used for being carried out by control module 33 and the data storage that applies pattern such as the calibration curve that adopts in the calculating of computing unit 34, correction data and voltage be in storage unit 35.Also be stored in the storage unit 35 bysensor part 4 detected response currents with by the concentration of glucose data that computing unit 34 calculates.

Control module 33, computing unit 34 and storage unit 35 can be by constructing such as CPU and/or the electric assembly that is installed in MPU, ROM and RAM on thecircuit board 3.

In the continuousglucose monitoring device 1 of such structure of this illustrative embodiments, under monitoring pattern, measure the response current when applying predetermined voltage pattern as shown in Figure 5.Under checking mode, the state ofsensor part 4 is checked in the variation that is based in the response current when applying the voltage that obtains the response that is caused by glucose, and specifically, checks the state ofsemipermeable partition 45.

Hereinafter describes the principle of the checking mode in the continuousglucose monitoring device 1 of first illustrative embodiments.

For example; Voltage mode shown in Figure 5 is to apply the voltage (hereinafter referred to as non-response voltage E1) that does not obtain the response that is caused by glucose to reach special period (in this example for apply-200mV reached for 240 seconds), reaches the pattern of special period (reaching for 120 seconds for applying 400mV in this example) with the after-applied voltage (response voltage E2 hereinafter referred to as) that obtains the response that is caused by glucose.Checking mode utilization in first illustrative embodiments follows the variable quantity in the response current after the applying of response voltage E2 closely.

Non-response voltage E1 is the voltage that glucose does not respond fully, and perhaps glucose shows the voltage of slight response (but being in the level that in fact can be regarded as non-response).More precisely, the response current when applying non-response voltage E1 tosensor part 4 comprise by glucose cause but the minimum response that mainly causes by external environment condition contextual factor (background that causes such as characteristic and the background and the noise of coexisting substances) by sensor.The value of non-response voltage E1 is provided with based on the standard of sensor part 4 (for example, according to such as the material of the amount of employed enzyme, the method that adheres to this enzyme, electrode and the factor of response region).The response initial voltage that begins to flow when more particularly, the non-response voltage E1 voltage that is in application tosensor part 4 according to the response current that is caused by glucose increases is set at-0.5V to+0.5V (be preferably-25mV is to+25mV) scope.

Response voltage E2 is the voltage that glucose shows enough responses.The value of response voltage E2 is provided with based on the standard of sensor part 4 (for example, such as the material of the amount of employed enzyme, the method that adheres to this enzyme, electrode and the factor of response region).

Fig. 5 illustration the response current when this voltage mode being applied to have semipermeable partition 45 a plurality of sensor of different conditions of (CA film).Concentration of glucose is 100mg/dL.The state of the CA film of each in corresponding a plurality of sensor is illustrated in figure 6 as: there is CA film (YesCA) (1) no CA film (NoCA), (2), and (3) to (6) simulated defect film with 4% concentration C A film of the part of covering sensor portion 4 (CA4%Spin A to CA4%Spin D) only.To Fig. 6 (3) to Fig. 6 (6), the part that is covered by the CA film than dark-part at place, the bottom of this figure.Ratio of defects (not by the ratio of the area of the area of CA film covering and sensor part) to each sensor is respectively: (1) 100%, (2) 0%, (3) 65%, (4) 64%, (5) 35% and (6) 10%.And, to (2) CA film (YesCA) is arranged, the CA film exemplified concentrations of preparation 2% (CA2%Spin), 3% (CA3%Spin) and 4% (CA4%Spin).Owing to the difficulty aspect the film thickness of actual measurement CA film, represent the film thickness of CA film through the concentration of film.

Among Fig. 7 illustration to each sensor, follow (the variable quantity in the response current after+the applying 400mV) closely at response voltage E2.The SI of being adopted was 5 seconds.Fig. 8 shows the variation delta nA/mm of illustration in the response current in per 5 seconds²The absolute value of/5s becomes and (is set to 0.2nA/mm here, less than specific change amount threshold value²) till the curve map of time.Find out from these curve maps, and compare to the thickest sensor CA4%Spin that the period till diminishing to the variation in response current than the sensor CA3%Spin of film thickness and CA2%Spin is morning.The reason of this time-related difference is assumed to be because the operating lag that limits based on the glucose permeability because of the CA film causes.And, and to compare having in the CA4%Spin of complete covered surfaces sensor, the period till the variation up to response current in the sensor with simulated defect film CA4%Spin A to CA4%Spin D diminishes is early.

The CA4%Spin sensor as normal condition, through utilizing these results, can be confirmed state and the impaired state of a part of CA film of the film thickness attenuation of CA film between fabrication phase or operating period.In this case, this variable quantity threshold value is 0.2nA/mm²Yet,, this variable quantity threshold value is according to coming suitably to be provided with such as the standard and the factor in sampling period ofsensor part 4.

With reference to Fig. 9, hereinafter is handled routine to the checking mode of during the checking mode of the continuousglucose monitoring device 1 of first illustrative embodiments, carrying out and is described.

Whether instep 100, being directed against is the confirming of timing that is used to carry out the processing of checking mode.For example, can confirm structure,, perhaps carry out checking mode on schedule, and confirm whether to arrive this time in this step so that per hour carry out checking mode.Can also construct so that the execution of checking mode regularly is confirmed as to be in continuous monitoring is influenced less night.Can also construct so that follow the timing of after bringing into use continuousglucose monitoring device 1, confirming the checking mode execution closely, for example, so that do not have the 7th day execution checking mode fast-changing, from bringing into use at the expection sensor states.If confirm to have reached execution timing, then handle and proceed to step 102 to checking mode.Yet, if confirm not reach as yet regularly to the execution of checking mode, the confirming of repeatingstep 100, up to confirm to have reached carry out regularly till.

Instep 102, apply response voltage E2.For example, apply+400mV voltage reached for 120 seconds.Then, instep 104, measure the variation delta I of response current at interval in (for example, 5 seconds) by particular sample.Then; Instep 106; Be utilized in timing that step 102 applies response voltage E2 point to start with, the measured variation delta I up to response current that calculates in the special period that applies response voltage E2 becomes less than the time T till the specific change amount threshold value Δ Ith.It should be noted that, be that the situation of absolute value is illustrated to the variation delta I of response current.Yet the variation delta I of response current is not limited to absolute value, but can adopt actual value.In this case, calculating becomes greater than the time T till the specific change amount threshold value Δ Ith up to the variation delta I of response current.In other words, can calculate time T till the variation delta I of response current reaches the value in the particular range.

Then,, time T and the time threshold Tth that calculates instep 106 compared, and be directed against whether confirming of time T less than time threshold Tth in step 108.Situation when having the sensor of normalsemipermeable partition 45 to employing becomes up to the variation delta I of response current and time threshold Tth is set less than the time till the variable quantity threshold value Δ Ith with reference to applying response voltage E2.For example, as shown in Figure 8, utilize CA4%Spin as normal sensor, can time threshold Tth be set by 70 ± α second (wherein, α can between 5 seconds in second to 20).If time T＜time threshold Tth, the state that then carries outsemipermeable partition 45 change confirming of (that is, defective having occurred), and processing proceeds to step 110.Yet if time T >=time threshold Tth, the state that carries outsemipermeable partition 45 does not change confirming of (that is,semipermeable partition 45 being in normal condition), and this processing finishes.

Instep 110, be based on the time T that step 106 calculates and derive the ratio of defects of semipermeable partition 45.Then, calculate the corrected value of proofreading and correct according to this ratio of defects, be directed against the response current that under monitoring pattern, to measure, and this corrected value is stored in the storage unit 35.

More particularly, at first, draw the relation between time T and the ratio of defects, shown in figure 10.For example, to each sensor shown in Figure 6, calculate variable quantity threshold value Δ Ith and be set at 0.2nA/mm²Situation under time T, and with transverse axis and on, draw to relation each sensor, between time T and the ratio of defects with the curve map of Z-axis as ratio of defects as time T.And this ratio of defects can be regarded as the film thickness (concentration) of CA film of sensor than the little ratio of film thickness (concentration) of the CA film of normal sensor.Derive the time T drawn and the correspondence between the ratio of defects, and this correspondence is stored in the storage unit 35 in advance.Then adopt the correspondence of time T and ratio of defects to derive and the corresponding ratio of defects of time T that calculates in step 106.For example, in the example of Figure 10, if time T was 60 seconds, then deriving ratio of defects is 31.5%.

Here, Figure 11 A shows the response current sensitivity that obtains 100 seconds after applying response voltage E2 and CA film (1) shown in Figure 6 to the relation between the ratio of defects of (6).It should be noted that, obtain response current sensitivity and be not limited to this timing, but can obtain response current sensitivity in any timing in the scope that has response current sensitivity that can the amount of distinguishing.Then, for example, shown in Figure 11 B, the ratio of defects of drawing sensor and sensitivity normally-relation between the mistake difference.With sensitivity normal-mistake difference is expressed as with normal response sensitivity as 100 ratio.According to this ratio of defects,, compare increase with α % with normal sensor to the point of confirming that can whether export response current.Derive the ratio of defects drawn and sensitivity normally-correspondence between the mistake difference, and this correspondence is stored in the storage unit 35 in advance.Then, adopt ratio of defects and sensitivity normal-correspondence between the mistake difference derive with the corresponding sensitivity of ratio of defects of being derived normally-mistake difference.For example, in the example of Figure 11, when this ratio of defects is 31.5%, derive about 185.2% sensitivity normal-mistake difference.Then, with this sensitivity normal-mistake difference is stored in the storage unit 35, and processing finishes.

Under monitoring pattern, utilize above-mentioned corrected value that the response current value of actual measurement is proofreaied and correct and be measured value/corrected value, then output is as measurement result.

As stated; According to the continuous glucose monitoring device of first illustrative embodiments, the time of adopting the state of checking semipermeable partition is that the variable quantity of the response current after following the voltage application of obtaining the response that is caused by glucose closely became less than the time till the predetermined variation amount threshold value.Therefore, can be stably and carry out the sensor states inspection in the very short time, and many group working electrodes need be set and to electrode.Specifically, because the variation that follows closely in the response current after voltage applies is used to inspection,, can make to the execution time of checking mode shorter so compare with the situation that adopts the time till response current reaches steady state (SS).Under the situation such as this illustrative embodiments of carrying out continuous monitoring, this is more effective.In first illustrative embodiments, the variation delta I based on the response current when having applied response voltage E2 (first voltage) become confirm that less than the time T till the variable quantity threshold value Δ Ith situation of the defective in the sensor is illustrated.Yet, can carry out following structure: the time T till using the variation delta I of the response current when having applied non-response voltage E1 to reach the value in the particular range.

(second illustrative embodiments)

Then, second illustrative embodiments is described.The difference of second illustrative embodiments and first illustrative embodiments is: be based on the ratio of defects that the variation delta I itself that has applied response voltage E2 response current afterwards confirms sensor.It should be noted that the structure of the continuousglucose monitoring device 1 of second illustrative embodiments is identical with the continuousglucose monitoring device 1 of first illustrative embodiments.Therefore, omitted explanation to this same configuration.

Hereinafter describes the principle of the checking mode in the continuousglucose monitoring device 1 of second illustrative embodiments.

As in first illustrative embodiments, Figure 12 illustration utilize each sensor shown in Figure 6, applying the response voltage E2 (+400mV) variable quantity in afterwards the response current of scheduled time slot (being 40 seconds) here.As can be seen from Figure 12, and compare to the thickest sensor CA4%Spin, to bigger than the variation in the response current of the sensor CA3%Spin of film thickness and CA2%Spin.This reason is assumed to be because the operating lag that limits based on the glucose permeability because of the CA film causes.And, and to compare having in the CA4%Spin of complete covered surfaces sensor, the variation of the response current in the sensor with simulated defect film CA4%Spin A to CA4%Spin D is bigger.

The CA4%Spin sensor as normal condition, through utilizing these results, can be confirmed state and the impaired state of a part of CA film of the film thickness attenuation of CA film between fabrication phase or operating period.

With reference to Figure 13, hereinafter is handled routine to the checking mode of during the checking mode of the continuousglucose monitoring device 1 of second illustrative embodiments, carrying out and is described.It should be noted that the same treatment that the checking mode of first illustrative embodiments is handled in the routine is composed with identical label, and has omitted the explanation to these same treatment.

Whether instep 100, being directed against is the confirming of timing that is used to carry out the processing of checking mode.If confirm to have reached execution timing, then handle and proceed to step 102 to checking mode.Yet if confirm not reach as yet to the execution of checking mode regularly, the confirming of repeatingstep 100 is till confirming to have reached this executions timing.

Instep 102, apply response voltage E2 and reach special time length.For example, apply+voltage of 400mV reached for 40 seconds.Then,, be utilized in the timing point to start with that applies response voltage E2 in thestep 102, after this measure the variation delta I of response current at special time instep 204.

Then, instep 208, whether the variation delta I that is directed against the response current of instep 204, measuring confirming greater than specific change amount threshold value.If confirm Δ I＞variable quantity threshold value Δ Ith, confirm that then the state ofsemipermeable partition 45 changes, that is, defective occurred, and processing proceeds to step 210.Yet, if confirm Δ I≤variable quantity threshold value Δ Ith, confirm that the state ofsemipermeable partition 45 does not change, that is,semipermeable partition 45 is in normal condition, and this processing finishes.It should be noted that, be that the situation of actual value is illustrated to the variation delta I of response current.Yet the variation delta I of response current is not limited thereto, but can adopt absolute value.In this case, the variation delta I that is directed against response current the confirming that whether become less than specific change amount threshold value Δ Ith.

Instep 210, the variation delta I that is based on the response current that step 204 calculates derives the ratio of defects of semipermeable partition 45.Then, calculate the corrected value of proofreading and correct according to this ratio of defects, be directed against the response current that under monitoring pattern, to measure, and this corrected value is stored in the storage unit 35.

More particularly, at first, draw the variation delta I of response current and the relation between the ratio of defects, shown in figure 14.For example, to each sensor shown in Figure 6, variable quantity threshold value Δ Ith is set at-0.2nA/mm², and represent that at transverse axis variation delta I and the Z-axis of response current represent to draw to the relation between variation delta I each sensor, response current and the ratio of defects on the curve map of ratio of defects.Derive the variation delta I of response current and the correspondence between the ratio of defects, and this correspondence is stored in the storage unit 35 in advance.Then adopt the correspondence of variation delta I and the ratio of defects of response current to derive the corresponding ratio of defects of variation delta I with the response current of measuring in step 204.Then, as in first illustrative embodiments, adopt ratio of defects and sensitivity normal-the relation that is derived between the mistake difference derive with the corresponding sensitivity of ratio of defects of being derived normally-mistake difference.

As stated, according to the continuous glucose monitoring device of second illustrative embodiments, will be used to check the state of semipermeable partition at the variable quantity of the response current of the special time after following the voltage application of obtaining the response that causes by glucose closely.Therefore, can be stably and carry out the sensor states inspection in the very short time, and many group working electrodes need be set and to electrode.Specifically, because the variation that follows closely in the response current after voltage applies is used to inspection,, can make to the execution time of checking mode shorter so compare with the situation that adopts the time till response current reaches steady state (SS).Under the situation such as this illustrative embodiments of carrying out continuous monitoring, this is more effective.

In second illustrative embodiments, the variation delta I of the response current when having applied response voltage E2 (first voltage) to being based on confirms that the situation of the defective in the sensor is illustrated.Yet, can carry out following structure: the variation delta I that uses the response current when having applied non-response voltage E1.

(the 3rd illustrative embodiments)

Then, the 3rd illustrative embodiments is described.The difference of the 3rd illustrative embodiments and first illustrative embodiments is: be based on the time T that applied after the response voltage E2 with applied after the non-response voltage E1 time T the two confirm the ratio of defects of sensor.It should be noted that the structure of the continuousglucose monitoring device 1 of the 3rd illustrative embodiments is identical with the continuousglucose monitoring device 1 of first illustrative embodiments.Therefore, omitted explanation to this same configuration.

In the continuousglucose monitoring device 1 of the 3rd illustrative embodiments, under monitoring pattern, measure the response current when having applied predetermined voltage pattern as shown in Figure 5.Under checking mode; Be based on the variation in the response current when having applied the voltage that obtains the response that causes by glucose; And be based on the variation of the response current when having applied the voltage that does not obtain the response that causes by glucose; Check the state ofsensor part 4, specifically, the state of inspectionsemipermeable partition 45.

Hereinafter describes the principle of the checking mode in the continuousglucose monitoring device 1 of the 3rd illustrative embodiments.

As in first illustrative embodiments, Figure 15 A illustration to each sensor shown in Figure 6, follow (the variable quantity in the response current after+the applying 400mV) closely at response voltage E2.Figure 15 B illustration to each sensor, the non-response voltage E1 (variable quantity in response current 200mV).It should be noted that Figure 15 A is identical with Fig. 7.The SI of being adopted was 5 seconds.Figure 16 A and Figure 16 B show the variation delta nA/mm of illustration in the response current in per 5 seconds²The absolute value of/5s becomes less than the curve map of the time till the specific change amount threshold value.Figure 16 A illustration has applied the curve map of response voltage E2, and Figure 16 B illustration has applied the curve map of non-response voltage E1.It should be noted that Figure 16 A is identical with Fig. 8.Variable quantity threshold value when having applied response voltage E2 is set at 0.2nA/mm², and the variable quantity threshold value when having applied non-response voltage E1 is set at 0.5nA/mm²Find out from these curve maps, and compare to the thickest sensor CA4%Spin that the period till diminishing to the variation in response current than the sensor CA3%Spin of film thickness and CA2%Spin is morning.The reason of this time-related difference when having applied response voltage E2 is assumed to be because the operating lag that limits based on the glucose permeability because of the CA film causes.The reason of this time-related difference when having applied non-response voltage E1 is assumed to be because the difference aspect the quantity of electric charge of electrostatic double layer that cause because of the difference in the state of CA film, on the electrode causes.With compare having in the CA4%Spin of complete covered surfaces sensor, the time till the variation up to response current in the sensor with simulated defect film CA4%Spin A to CA4%Spin D diminishes is early.

The CA4%Spin sensor as normal condition, through utilizing these results, can be confirmed state and the impaired state of a part of CA film of the film thickness attenuation of CA film between fabrication phase or operating period.Variable quantity threshold value when in this case, having applied response voltage E2 is 0.2nA/mm², and the variable quantity threshold value when having applied non-response voltage E1 is 0.5nA/mm²Yet,, this variable quantity threshold value is according to coming suitably to be provided with such as the standard and the factor in sampling period ofsensor part 4.

With reference to Figure 17, hereinafter is handled routine to the checking mode of during the checking mode of the continuousglucose monitoring device 1 of the 3rd illustrative embodiments, carrying out and is described.

Whether instep 300, being directed against is the confirming of timing that is used to carry out the processing of checking mode.If confirm to have reached execution timing, then handle and proceed to step 302 to checking mode.Yet if confirm not reach as yet to the execution of checking mode regularly, the confirming of repeatingstep 300 is till confirming to have reached this executions timing.

Instep 302, apply non-response voltage E1 and reach special period.For example, apply-voltage of 200mV reached for 240 seconds.Then, in step 304, measure the variation delta I of response current at interval in (for example, 5 seconds) by particular sample_E1Then, instep 306, the timing when being utilized instep 302 and having applied non-response voltage E1 is point to start with, calculates the measured variation delta I up to response current_E1Become less than specific change amount threshold value Δ Ith_E1Till time T_E1It should be noted that, to the variation delta I of response current_E1The situation that is absolute value is illustrated.Yet, the variation delta I of response current_E1Be not limited to absolute value, but can adopt actual value.In this case, calculating is up to the variation delta I of response current_E1Become greater than specific change amount threshold value Δ Ith_E1Till time T_E1In other words, can calculate variation delta I up to response current_E1Reach the time T till the value in the particular range_E1This is equally applicable to the variation delta I of response current cited below_E2

Then, instep 308, apply response voltage E2 and reach special period.For example, apply+400mV reached for 120 seconds.Then, instep 310, measure the variation delta I of response current at interval in (for example, per 5 seconds) by particular sample_E2Then, instep 312, the timing when being utilized instep 308 and applying response voltage E2 is point to start with, calculates the variation delta I up to response current_E2Become less than specific change amount threshold value Δ Ith_E2Till time T_E2

Then, in step 314, to the time T that calculates in step 306_E1With time threshold Tth_E1Compare, and the time T to calculating in step 312_E2With time threshold Tth_E2Compare.Then, be directed against time T_E1Whether less than time threshold Tth_E1And time T_E2Whether less than time threshold Tth_E2Confirming of the two.Situation when having adopted the sensor with normal semipermeable partition 45 is with reference to applying the variation delta I of non-response voltage E1 up to response current_E1Become less than variable quantity threshold value Δ Ith_E1Till time this time threshold Tth is set_E1Similarly be that the situation when having adopted the sensor with normal semipermeable partition 45 is with reference to applying the variation delta I of response voltage E2 up to response current_E2Become less than variable quantity threshold value Δ Ith_E2Till time this time threshold Tth is set_E2For example, shown in Figure 16 A, when when the CA4%Spin as normal sensor applies response voltage E2, time threshold Tth_E2Can be set at 70 ± α second.Similarly be, shown in Figure 16 B, when applying non-response voltage E1 to CA4%Spin as normal sensor, time threshold Tth_E1Can be set at 58 ± α second.Here, for example, α can be set between 5 seconds in second to 20.If time T_E1＜time threshold Tth_E1And time T_E2＜time threshold Tth_E2, the state that then carries out semipermeable partition 45 changes confirming of (that is, defective having occurred), and processing proceeds to step 320.Yet, if time T_E1>=time threshold Tth_E1And/or time T_E2>=time threshold Tth_E2, then handle and proceed to step 316.

Instep 316, whether be directed against time T_E1Less than time threshold Tth_E1But time T_E2Be equal to or greater than time threshold Tth_E2Confirm, whether perhaps be directed against time T_E1Be equal to or greater than time threshold Tth_E1But time T_E2Less than time threshold Tth_E2Confirm.That is, be directed against whether confirming of in the time T or another less than corresponding time threshold Tth.If carried out negative confirming owing to two time T all are equal to or greater than corresponding time threshold Tth, the state that then carries outsemipermeable partition 45 does not change confirming of (that is, the state ofsemipermeable partition 45 being normal), and processing finishes.Yet if confirm that only a time T is handled and proceeded to step 318 less than time threshold Tth, instep 318, whether the processing that is directed againststep 314 or step 316 has been confirming of rechecking.If, then handle being back to step 302, and repeat this processing and carry out rechecking when pre-treatment is primary processing.Yet, if carry out this processing, sensor status is confirmed as normally, and processing finishes as rechecking.

Instep 320, be based on the time T that step 312 calculates_E2Derive the ratio of defects ofsemipermeable partition 45, calculate corrected value, and this corrected value is stored in the storage unit 35 to the response current of in monitoring pattern, measuring according to this ratio of defects.

More particularly, at first, draw time T_E2And the relation between the ratio of defects is shown in Figure 18 A.For example, to each sensor shown in Figure 6, calculate variable quantity threshold value Δ Ith is being arranged on 0.2nA/mm²Situation under time T_E2, and at transverse axis express time T_E2And Z-axis represent to draw on the curve map of ratio of defects to each sensor, time T_E2And the relation between the ratio of defects.It should be noted that Figure 18 A is identical with Figure 10.Derive the time T of being drawn_E2And the correspondence between the ratio of defects, and this correspondence is stored in the storage unit 35 in advance.Then adopt time T_E2Derive and the time T that calculates in step 312 with the correspondence of ratio of defects_E2Corresponding ratio of defects.For example, in the example of Figure 18 A, if time T_E2Be 60 seconds, then deriving ratio of defects is 31.5%.Shown in Figure 18 B, in definite time T_E1During with the correspondence of ratio of defects, can be employed in the time T that step 306 calculates_E1Derive this ratio of defects.Alternatively, can construct so that derive based on time T_E1Ratio of defects and based on time T_E2Ratio of defects the two, and the mean value, higher value or the smaller value that then adopt these ratio of defects are as this ratio of defects.Then, as in first illustrative embodiments, adopt ratio of defects and sensitivity normal-the relation that is derived between the mistake difference derive with the corresponding sensitivity of ratio of defects of being derived normally-mistake difference.

As stated; Continuous glucose monitoring device according to the 3rd illustrative embodiments; The time that is used for checking the state ofsemipermeable partition 45 is to become less than the time till the predetermined threshold up to the variable quantity that follows the response current after having applied the voltage that obtains the response that is caused by glucose closely, and up to the variable quantity that follows the response current after having applied the voltage that does not obtain the response that causes by glucose closely become less than the time till the predetermined threshold the two.Therefore, can be in the very short time, stably and with good precision carry out the sensor states inspection, and many group working electrodes need be set and to electrode.Specifically, because the variation that follows closely in the response current after voltage applies is used to inspection,, can make to the execution time of checking mode shorter so compare with the situation that adopts the time till response current reaches steady state (SS).Under the situation such as this illustrative embodiments of carrying out continuous monitoring, this is more effective.

In the 3rd illustrative embodiments, to confirming that the variable quantity up to following the response current after the applying of non-response voltage E1 closely becomes less than the time T till the predetermined variation amount_E1, and become less than the time T till the predetermined variation amount up to the variable quantity that follows the response current after the applying of response voltage E2 closely_E2The two is less than specific respective threshold (Tth_E1And Tth_E2) time, confirm that the situation that occurs defective in the sensor is illustrated.Yet, can construct so that only at T_E1＜Tth_E1The time confirm to occur in the sensor defective.Because to the response current of non-response voltage E1 is the background response electric current that the characteristic by the sensor that comprises outer membrane causes; And do not comprise the response current that causes by glucose; So can through utilizing to the variation in the response current of non-response voltage E1 to confirm whether there is defective in the sensor, improve definite precision.And; Under the situation that additionally adopts the variable quantity that adopts the response current that is directed against non-response voltage E1 to the variable quantity ground in the response current of response voltage E2 at least; Then adopt and confirm, thereby can further improve definite precision to the variation in the response current of two different voltages.

To being illustrated applying the situation that non-response voltage E1 (step 302 to step 306) applies response voltage E2 (step 308 to step 312) afterwards in the 3rd illustrative embodiments.Yet, can construct so that the at first processing of execution instep 308 to step 312 to apply response voltage E2, is followed the processing of execution instep 302 to step 306, to apply non-response voltage E1.

In the 3rd illustrative embodiments, to the variable quantity of every special time that will follow the response current after each voltage application closely as the variation of response current and adopt situation about becoming less than the time till the predetermined variation amount to be illustrated up to variable quantity.Yet, be not limited to these situation, but can construct so that adopt rate of change or the changing pattern that follows the response current after each voltage application closely to the variation of response current.

And, as in second illustrative embodiments, can also be employed in the variable quantity in the response current that applies scheduled time slot after response voltage and the non-response voltage.In this case, Figure 19 illustration utilize each sensor shown in Figure 6 applying the non-response voltage E1 (200mV) variable quantity in the response current of scheduled time slot (being 40 seconds) afterwards here.It should be noted that the variable quantity in the response current when applying non-response voltage E1 is identical with Figure 12.As can be seen from Figure 19, and compare to the thickest sensor CA4%Spin, to less than the variation in the response current of the sensor CA3%Spin of film thickness and CA2%Spin.The reason of this time-related difference is assumed to be because the difference of the quantity of electric charge aspect of electrostatic double layer that cause because of the difference of the state aspect of CA film, on the electrode causes.And, to compare with having through the CA4%Spin of complete covered surfaces sensor, the variation with the response current in the sensor of simulated defect film CA4%Spin A to CA4%Spin D is less.Utilize this result,,, can confirm the variation delta I of response current and the correspondence of ratio of defects like Figure 14 and shown in Figure 20 as in second illustrative embodiments.

And; In the 3rd illustrative embodiments, as shown in Figure 5, the situation of the voltage mode that alternately applies non-response voltage E1 and response voltage E2 is illustrated; Yet this voltage mode needn't be always the pattern that alternately applies non-response voltage E1 and response voltage E2.For example,, can construct to shown in Figure 21 (4) like Figure 21 (1) so that utilize the combination of a plurality of constant voltages progressively to apply voltage with different electromotive forces.Can construct so that comprise three constant voltages at first step (apply state that non-response voltage E1 reaches fixing period with apply response voltage E2 reach the fixedly first step of the combination of the state of period); Like Figure 21 (1) to shown in Figure 21 (4); Yet the quantity of constant voltage can be set to 2 or 4 or more a plurality of.The increase of the quantity of point that therefore, can be through changing electromotive force improves the inspection frequency of outer membrane.

And, in above each illustrative embodiments, the situation that analytical equipment of the present invention is applied to continuous glucose monitoring device is illustrated, yet the monitoring objective material that will check is not limited to glucose.And, be not limited to be applied to the CGM device, and can be applied to the monitoring certainly of blood glucose (SMBG) device.In these cases, can construct so that through carrying out inspection by the checking mode of user's selection with by the sample liquid that the user is dropped on the sensor part.

In above each illustrative embodiments; The situation of calculated correction value is illustrated during to the defective in detecting sensor (semipermeable partition); Yet; Can construct so that occurred the signal of defective in the time output expression of the defective in the detecting sensor sensor, and, perhaps even not calculate this corrected value to output calculated correction value with this signal.In these cases, can construct, and during the defective in detecting sensor, the signal of defective to warning unit output expression sensor, occur from output unit so that output unit and warning unit are set to analytical equipment.More particularly; Display, loudspeaker or vibration unit unit by way of caution can be set, so that on display, be presented at the message that occurred defective in the sensor, when receiving the signal from output unit from the loudspeaker output sound or in the warning unit this device vibrated.Can also construct so that export for example external data treatment facility to, and carry out in sensor, having occurred the warning of defective through the warning unit that is set to this external data treatment facility from the signal of output unit.It should be noted that, the warning unit structure be not limited to above with reference to example.

In above each illustrative embodiments, be illustrated applying the situation that response voltage and non-response voltage reach special period.Yet, can construct so that stop to apply response voltage and non-response voltage at the time point of the variable quantity of confirming response current during less than the variable quantity threshold value, then carry out subsequent treatment.

In above each illustrative embodiments, the situation that the end (electrode part) with sensor part is configured to example shown in Figure 3 is illustrated, yet, can adopt other structure.For example, can construct, so that shown in Figure 22 (1), cover the workingelectrode 42A of portion and, perhaps can be stacked in thesemipermeable partition 45 on thereagent layer 44 by cambium layer, shown in Figure 22 (2)electrode part 42B so that form semipermeable partition 45.It should be noted thatenzyme part 43 is set in the reagent layer of the 42A of working electrode portion top, but in Figure 22, has omittedenzyme part 43.

There is not special restriction in storage medium to being used to store program of the present invention, and for example can utilize hard disk or ROM to construct.Can also utilize CD-ROM, DVD dish, magneto-optic disk or IC-card to construct.Can also construct so that download this program from device such as the server that is connected to network.

Claims (13)

1. analytical equipment, this analytical equipment comprises:

Sensor part; This sensor part comprises reagent layer, electrode and outer membrane; Said reagent layer comprise with sample liquid in the reagent of substance reaction; Said electrode comprises first electrode and second electrode that is used for applying to said reagent layer voltage, and said outer membrane is used for contacting with said reagent layer;

Voltage applying unit; This voltage applying unit is used between said first electrode and said second electrode, applying at least one of first voltage and second voltage; Said first voltage obtains the response that is caused by said material, and said second voltage does not obtain or do not obtain basically the response that is caused by said material;

Current measuring unit, this current measuring unit are used to measure the electric current that between said first electrode and said second electrode, flows; And

Confirm the unit; Should confirm that unit was used for confirming whether there is defective in the said outer membrane based on first physical quantity and second physical quantity at least one; Said first physical quantity is relevant with the variable quantity of every special time of first electric current of when having applied said first voltage, having been measured by said current measuring unit, and said second physical quantity is relevant with the variable quantity of every special time of second electric current of when having applied said second voltage, having been measured by said current measuring unit.

2. analytical equipment according to claim 1; Wherein, Said first physical quantity is the very first time till the variable quantity up to said every special time of said first electric current reaches the value in predetermined first particular range, and said second physical quantity is second time till the variable quantity up to said every special time of said second electric current reaches the value in predetermined second particular range.

3. analytical equipment according to claim 1; This analytical equipment also comprises correcting unit; Proofread and correct the said current value of being measured by said current measuring unit when this correcting unit is confirmed defective to have occurred in the said outer membrane in said definite unit, at least one during said correcting unit concerns based on second of being scheduled between the ratio of defects of the first predetermined relation between the ratio of defects of said first physical quantity and said outer membrane and said second physical quantity and said outer membrane carried out correction.

4. analytical equipment according to claim 3; Wherein, During said correcting unit concerns based on said first relation and said second at least one estimated said ratio of defects; And the predetermined relationship between the said current value of measuring based on the said ratio of defects of said outer membrane and from following sensor part is proofreaied and correct the said current value of being measured by said current measuring unit, and wherein this sensor part is provided with and has and the corresponding external defect sealing film of said ratio of defects.

5. analytical equipment according to claim 4; Wherein, When said correcting unit based on said first relation with said second when concern that the two estimates said ratio of defects, said correcting unit calculate based on said first concern first ratio of defects that estimates and based on said second concern second ratio of defects that estimates mean value, maximal value or minimum value as said ratio of defects.

6. analytical equipment according to claim 1, this analytical equipment also comprises output unit, output was illustrated in the signal that has occurred defective in the said sensor part when this output unit was confirmed defective to have occurred in the said outer membrane in said definite unit.

7. analytical equipment according to claim 1, wherein, apply said first voltage and said second voltage the two time, said voltage applying unit alternately applies said first voltage and said second voltage.

8. analytical equipment according to claim 1, wherein, the electric current that said current measuring unit continuous coverage is flowed between said first electrode and said second electrode, and said definite unit regularly confirms whether there is defective in the said outer membrane by predetermined.

9. analytical equipment according to claim 1, wherein, use said analytical equipment during, said sensor part is set under user's the skin of said analytical equipment, and said reagent layer reacts with the composition to be checked that is present in said skin under.

10. analytical equipment according to claim 1, wherein, said reagent layer extracts electronics from said composition to be checked, and the electronics that is extracted is offered said electrode.

11. analytical equipment according to claim 1, wherein, said reagent layer comprises the enzyme part that is used for extracting from said composition to be checked electronics.

12. a sensor testing fixture, this sensor testing fixture comprises:

Voltage applying unit; This voltage applying unit applies at least one in first voltage and second voltage between first electrode of sensor part and second electrode; This first voltage obtains the response that is caused by material; This second voltage does not obtain or does not obtain the response that is caused by said material basically, and said sensor part disposes reagent layer, electrode and outer membrane, said reagent layer comprise with sample liquid in the reagent of said substance reaction; Said electrode comprises said first electrode and said second electrode that is used for applying to said reagent layer voltage, and said outer membrane is used for contacting with said reagent layer;

Current measuring unit, this current measuring unit is measured the electric current that between said first electrode and said second electrode, flows; And

Confirm the unit; Should confirm unit confirms whether there is defective in the said outer membrane based in first physical quantity and second physical quantity at least one; Said first physical quantity is relevant with the variable quantity of every special time of first electric current of when having applied said first voltage, having been measured by said current measuring unit, and said second physical quantity is relevant with the variable quantity of every special time of second electric current of when having applied said second voltage, having been measured by said current measuring unit.

13. a sensor inspection method, this sensor inspection method may further comprise the steps:

Between first electrode of sensor part and second electrode, apply at least one in first voltage and second voltage; This first voltage obtains the response that is caused by material; This second voltage does not obtain or does not obtain basically the response that is caused by said material; Said sensor part disposes reagent layer, electrode and outer membrane; Said reagent layer comprise with sample liquid in the reagent of said substance reaction, said electrode comprises said first electrode and said second electrode that is used for applying to said reagent layer voltage, said outer membrane is used for contacting with said reagent layer;

The electric current that measurement is flowed between said first electrode and said second electrode; And

Confirm whether there is defective in the said outer membrane based in first physical quantity and second physical quantity at least one; Said first physical quantity is relevant with the variable quantity of every special time of first electric current of when having applied said first voltage, having measured, and said second physical quantity is relevant with the variable quantity of every special time of second electric current of when having applied said second voltage, having measured.

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